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临床试验/NCT04906317
NCT04906317招募中不适用

The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps: a Single-center, Prospective, Randomized Controlled Study

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
340
试验地点
1
主要终点
The score of visual analogue scoring (VAS)

研究概览

简要总结

This study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.

详细描述

Colorectal polyps are precancerous lesions of the colorectal cancer. Colonoscopy can reduce the risk of colorectal cancer. Painless endoscopy could reduce patient discomfort and improves the acceptance of treatment, especially for the endoscopic treatment of colorectal polyps. Intravenous anesthesia colonoscopy has a strong sedative effect and has obvious inhibitory effects on the respiratory and circulatory systems. It requires the assistance of an anesthesiologist. The lack of anesthesiologists makes it difficult to make an appointment for anesthesia colonoscopy, which is a bottleneck in the diagnosis and treatment of gastrointestinal diseases in China. Therefore, there is an urgent need to find a painless diagnosis and treatment method that is not inferior to anesthesia colonoscopy in comfort to meet the needs of patients. Comparing to anesthesia colonoscopy, sedative and analgesic colonoscopy have similar sedative and analgesic effects and do not require the assistance of an anesthesiologist. However, there is no relevant evaluation on the effectiveness of sedation and analgesia during the endoscopic treatment of colorectal polyps. Our department has used midazolam combined with dezocine to treat 185 patients with colorectal polyps in these years. Retrospective analysis showed that the sedative and analgesic effect is satisfactory. Therefore, it is necessary to make a single-center randomized parallel group controlled non-inferiority study to directly compare the effectiveness of sedation and analgesia versus intravenous anesthesia in endoscopic treatment of colorectal polyps.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colonoscopy diagnosed as a colorectal polyp, the number of polyps is less than 5, and the size of single polyp is less than 2.0 cm
  • Age more than 18 years and less than 70 years

排除标准

  • Allergy to propofol, dezocine, midazolam or eggs
  • ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
  • Suspected of gastrointestinal perforation, bleeding or obstruction
  • Acute gastrointestinal infection period
  • History of abdominal surgery
  • Patients during pregnancy or lactation

研究组 & 干预措施

Sedation and Analgesia

Active Comparator

0.05 mg/kg midazolam and 5mg dezocine iv infusion

干预措施: midazolam and dezocine (Drug)

Anesthesia

Active Comparator

continuous 1.5mg/kg propofol iv infusion

干预措施: Propofol (Drug)

结局指标

主要结局

The score of visual analogue scoring (VAS)

时间窗: immediately after the procedure of colonoscopy

Assess immediately after the completement of colonoscopy

次要结局

  • Treatment fee(During the colonoscopy procedure)

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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